EXCLUSIVE LICENSE AND OPTION AGREEMENT by and between FibroGen, Inc. and HiFiBiO (HK) Limited (d.b.a. HiFiBiO Therapeutics) Dated as of June 16, 2021
Execution Version
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the company if publicly disclosed.
Exhibit 10.2
EXCLUSIVE LICENSE AND OPTION AGREEMENT
by and between
FibroGen, Inc.
and
HiFiBiO (HK) Limited (d.b.a. HiFiBiO Therapeutics)
Dated as of June 16, 2021
TABLE OF CONTENTS
ARTICLE 1 DEFINITIONS |
1 |
|
ARTICLE 2 LICENSES AND EXCLUSIVITY |
13 |
|
2.1 |
License to XxxxxXxx |
00 |
2.2 |
License to HFB |
13 |
2.3 |
Sublicensing |
13 |
2.4 |
Subcontractors |
14 |
2.5 |
No Implied Licenses; Retained Rights |
14 |
2.6 |
Third Party In-Licenses |
14 |
2.7 |
Technology Transfer |
14 |
2.8 |
Exclusivity |
16 |
2.9 |
FibroGen License Options |
17 |
ARTICLE 3 GOVERNANCE |
19 |
|
3.1 |
Alliance Manager |
19 |
3.2 |
Joint Steering Committee |
19 |
3.3 |
Resolution of JSC Disputes |
21 |
3.4 |
Dissolution of JSC |
22 |
ARTICLE 4 DEVELOPMENT |
22 |
|
4.1 |
Development Plans |
22 |
4.2 |
Work Plans |
22 |
4.3 |
FibroGen Development Responsibilities |
23 |
4.4 |
Development Diligence Obligations |
23 |
4.5 |
HFB Development Responsibilities |
23 |
4.6 |
Development Records |
23 |
4.7 |
Development Reports |
23 |
ARTICLE 5 REGULATORY |
24 |
|
5.1 |
Regulatory Responsibilities |
24 |
5.2 |
Regulatory Filings; Ownership |
24 |
5.3 |
Interactions with Regulatory Authorities |
24 |
5.4 |
Option Programs |
24 |
ARTICLE 6 MANUFACTURING |
24 |
|
6.1 |
Manufacturing |
24 |
i
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the company if publicly disclosed.
ARTICLE 7 COMMERCIALIZATION |
25 |
|
7.1 |
Commercialization Responsibilities |
25 |
7.2 |
Commercialization Diligence Obligations |
25 |
7.3 |
Commercialization Report |
25 |
ARTICLE 8 FINANCIALS |
25 |
|
8.1 |
Upfront Payment |
25 |
8.2 |
Option Exercise Payment |
25 |
8.3 |
Milestone Payments |
26 |
8.4 |
Royalties |
27 |
8.5 |
Sublicense Revenue |
28 |
8.6 |
Upstream License Costs |
28 |
8.7 |
Books and Records; Audit Rights |
28 |
8.8 |
Taxes |
29 |
ARTICLE 9 INTELLECTUAL PROPERTY |
31 |
|
9.1 |
Background Technology |
31 |
9.2 |
Ownership |
31 |
9.3 |
Prosecution, Maintenance & Enforcement |
32 |
9.4 |
Defense and Settlement of Third Party Claims |
34 |
9.5 |
Enforcement |
34 |
9.6 |
Trademarks |
35 |
9.7 |
CREATE Act |
35 |
9.8 |
Patent Right Extensions; Regulatory Exclusivity |
36 |
ARTICLE 10 REPRESENTATIONS, WARRANTIES, AND COVENANTS |
36 |
|
10.1 |
Mutual Representations, Warranties, and Covenants |
36 |
10.2 |
Representations and Warranties by HFB |
37 |
10.3 |
HFB Covenants |
40 |
10.4 |
Mutual Covenants |
41 |
10.5 |
NO OTHER REPRESENTATIONS OR WARRANTIES |
41 |
ARTICLE 11 INDEMNIFICATION |
42 |
|
11.1 |
Indemnification by HFB |
42 |
11.2 |
Indemnification by XxxxxXxx |
00 |
11.3 |
Indemnification Procedures |
43 |
11.4 |
Limitation of Liability |
43 |
ii
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the company if publicly disclosed.
11.5 |
Insurance |
44 |
ARTICLE 12 CONFIDENTIALITY |
44 |
|
12.1 |
Confidentiality; Exceptions |
44 |
12.2 |
Authorized Disclosure |
45 |
12.3 |
Prior Agreement |
46 |
12.4 |
Residual Knowledge |
46 |
12.5 |
Publications |
47 |
ARTICLE 13 TERM AND TERMINATION |
47 |
|
13.1 |
Term |
47 |
13.2 |
Termination by XxxxxXxx |
00 |
13.3 |
Termination for Cause |
47 |
13.5 |
Termination for Patent Challenge |
49 |
13.6 |
Effects of Termination |
49 |
13.7 |
Survival |
51 |
ARTICLE 14 DISPUTE RESOLUTION |
52 |
|
14.1 |
Dispute Resolution |
52 |
14.2 |
Injunctive Relief |
53 |
ARTICLE 15 MISCELLANEOUS |
54 |
|
15.1 |
Entire Agreement; Amendment |
54 |
15.2 |
Force Majeure |
54 |
15.3 |
Notices |
54 |
15.4 |
No Strict Construction; Headings |
56 |
15.5 |
Interpretation |
56 |
15.6 |
Assignment |
57 |
15.7 |
Change of Control |
57 |
15.8 |
Performance by Affiliates |
57 |
15.9 |
Further Actions |
57 |
15.10 |
Severability |
57 |
15.11 |
No Waiver |
58 |
15.12 |
Independent Contractors |
58 |
15.13 |
Counterparts |
58 |
15.14 |
Choice of Law |
58 |
iii
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the company if publicly disclosed.
EXCLUSIVE LICENSE AND OPTION AGREEMENT
THIS EXCLUSIVE LICENSE AND OPTION AGREEMENT (this “Agreement”) is entered into as of June 16, 2021 (the “Effective Date”) by and among HiFiBiO (HK) Limited (d.b.a. HiFiBiO Therapeutics), a limited company organized and existing under the laws of Hong Kong, with a registered address at Xxxx 000, Xxxxx Xxxxx, Xx. Xxxxxx’s Xxxxxxxx, 0 Xxx Xxxxx Xxxxxx, Xxxxxxx, Xxxx Xxxx (“HFB”), and FibroGen, Inc., a Delaware corporation having its principal place of business at 000 Xxxxxxxx Xx., Xxx Xxxxxxxxx, XX 00000 (“FibroGen”). HFB and FibroGen are referred to herein individually as a “Party” and collectively as the “Parties.”
BACKGROUND
WHEREAS, HFB and its Affiliates Control certain Patent Rights and Know-How relating to the Gal-9 Licensed Program;
WHEREAS, HFB and its Affiliates Control certain Patent Rights and Know-How relating to, and are conducting research and Development with respect to, compounds and products directed to CCR8, CXCR5, and other targets.
WHEREAS, HFB desires to grant, and FibroGen desires to receive, an exclusive license under such Patent Rights and Know-How to permit FibroGen to Exploit Licensed Compounds and Licensed Products directed to Gal-9 in the Territory.
WHEREAS, HFB desires to grant, and FibroGen desires to receive, an exclusive option to receive an exclusive license to Exploit (a) Licensed Compounds and Licensed Products directed to CCR8, (b) Licensed Compounds and Licensed Products directed to CXCR5 or, (c) in the event FibroGen does not wish to exercise such option with respect to (a) or (b), Licensed Compounds and Licensed Products that are directed to a target that is the subject of another program Controlled by HFB and selected by the Parties.
NOW THEREFORE, the Parties agree as follows:
1.3 |
“Additional Third Party IP” has the meaning set forth in Section 2.6 (Third Party In-Licenses). |
1.4 |
“Affiliate” means, with respect to a Party, a Person that controls, is controlled by, controlling or is under common control with such Party, but only for so long as such control will continue. For the purposes of this definition, the word “control” (including, with correlative meaning, the terms “controlled by”, “controlling” or “under the common control with”) means the actual power, either directly or indirectly through one or more intermediaries, to direct or cause the direction of the management and policies of such entity, whether by the ownership of more than fifty percent (50%) of the voting stock of such entity, or by contract or otherwise. |
1.5 |
“Agreement” has the meaning set forth in the Preamble. |
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the company if publicly disclosed.
1.6 |
“Alliance Manager” has the meaning set forth in Section 3.1 (Alliance Manager). |
1.7 |
“Arbitration Forum” has the meaning set forth in Section 14.1(b) (Dispute Resolution). |
1.8 |
“Arising Know-How” has the meaning set forth in Section 9.2(a)(i) (Arising Technology). |
1.9 |
“Arising Patent Rights” has the meaning set forth in Section 9.2(a)(i) (Arising Technology). |
1.10 |
“Arising Technology” has the meaning set forth in Section 9.2(a)(i) (Arising Technology). |
1.11 |
“Bankruptcy Code” has the meaning set forth in Section 13.4 (Termination for Bankruptcy). |
1.12 |
“Bankruptcy Event” means, with respect to a Person, such person makes a general assignment for the benefit of creditors, admits in writing its inability to pay its debts generally as they become due, files or consents to the filing of a petition for bankruptcy or insolvency, the appointment of any receiver, liquidator, trustee or similar officer to liquidate or conserve its business or any substantial part of its assets, or files a petition or answer or consent seeking under the laws of any jurisdiction any proceeding for its insolvency, bankruptcy, reorganization, adjustment of debt, arrangement, dissolution, liquidation, or any case or action is taken against such Person by a third person in furtherance of any of the foregoing and such case or action by a third person is not dismissed within [*]. |
1.13 |
“Bankruptcy Laws” has the meaning set forth in Section 13.4 (Termination for Bankruptcy). |
1.14 |
“Biosimilar Product” means, with respect to a particular Licensed Product in a particular country, a product on the market in such country commercialized by any Third Party that is not an Affiliate or Sublicensee of FibroGen and that did not purchase such product in a chain of distribution that included any of FibroGen or its Affiliates or Sublicensees, that (a) is approved by the applicable Regulatory Authority, under any then-existing laws and regulations in the applicable country pertaining to approval of products with no clinically meaningful differences as a “generic”, “biosimilar”, or “interchangeable” version (or terms of similar meaning) of such Licensed Product, which approval uses such Licensed Product as a reference product and relies on or references any information in the approval application for such Licensed Product, or (b) is otherwise recognized by the applicable Regulatory Authority as a “generic”, “biosimilar” or “interchangeable” product (or other term of similar meaning) with no clinically meaningful differences to such Licensed Product. |
1.15 |
“BLA” means a Biologics License Application submitted to the FDA pursuant to Section 351 of the Public Health Service Act, 42 U.S.C. § 262, and 21 C.F.R § 601.2 as these provisions may be amended from time-to-time (or its successor statute or regulation), for purposes of obtaining Regulatory Approval for a biological product in the United States, or any equivalent filing in a country or regulatory jurisdiction other than the United States. |
1.16 |
“Business Day” means a day other than a Saturday, Sunday, or a day on which banking institutions in San Francisco, CA or Hong Kong are required by applicable law to remain closed. |
1.17 |
“Calendar Quarter” means a period of three consecutive months ending on the last day of March, June, September, or December, respectively, except that the first Calendar Quarter of the Term shall commence on the Effective Date and end on the first to occur of March 31, June 30, September 30 or December 31 after the Effective Date, and the last Calendar Quarter shall end on the last day of the applicable Royalty Term or the Term, as applicable. |
1.18 |
“Calendar Year” means a period of 12 consecutive months beginning on January 1 and ending on December 31, except that the first Calendar Year of the Term shall commence on the Effective Date and end on December 31 of the year in which the Effective Date occurs, and the last Calendar |
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the company if publicly disclosed.
Year shall commence on January 1 of the year, end on the last day, of the applicable Royalty Term or the Term, as applicable. |
1.19 |
“CCR8” means [*]. |
1.20 |
“CCR8 Option Program” means the program of Development of the Option Compounds and Option Products Directed To CCR8. |
1.21 |
“cGMP” means applicable current Good Manufacturing Practices, including, as applicable, (a) the principles detailed in the U.S. Current Good Manufacturing Practices, 21 C.F.R. Parts 4, 210, 211, 601, 610 and 820, (b) European Directive 2003/94/EC and Eudralex 4, (c) the principles detailed in the International Conference on Harmonization’s Q7 guidelines, and (d) the applicable laws the Territory corresponding to (a) through (c) above, each as may be amended and applicable from time to time. |
1.22 |
“Chairperson” has the meaning set forth in Section 3.2(a) (Joint Development Committee). |
1.23 |
“Change of Control” means, with respect to a Party, that: (a) any Third Party acquires directly or indirectly the beneficial ownership of any voting security of such Party, or if the percentage ownership of such Third Party in the voting securities of such Party is increased through stock redemption, cancellation, or other recapitalization, and immediately after such acquisition or increase such Third Party is, directly or indirectly, the beneficial owner of voting securities representing more than 50% of the total voting power of all of the then outstanding voting securities of such Party; (b) a merger, consolidation, recapitalization, or reorganization of such Party is consummated that would result in shareholders or equity holders of any Third Party immediately prior to such transaction, owning more than 50% of the outstanding voting securities of the surviving entity (or its parent entity) immediately following such transaction; or (c) there is a sale or transfer to a Third Party of all or substantially all of such Party’s consolidated assets taken as a whole, in each of (a) through (c) through one or more related transactions. |
1.24 |
“Claim” has the meaning set forth in Section 11.3 (Indemnification Procedures). |
1.25 |
“Clinical Trial” means a study in humans to obtain information regarding a product, including information relating to the safety, tolerability, pharmacological activity, pharmacokinetics, dose ranging or efficacy of such product, including a Phase I Clinical Trial, Phase II Clinical Trial, and Phase III Clinical Trial. |
1.26 |
“CMO” means a contract manufacturing organization. |
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the company if publicly disclosed.
1.29 |
“Commercially Reasonable Efforts” means, with respect to the efforts to be expended by a Party or its Affiliate with respect to any Development or Commercialization objective, obligation, activity, or goal related to a Licensed Product under this Agreement, those efforts and resources that a [*] would normally devote to accomplishing such objective, obligation, activity or goal, based on the specific product and conditions then prevailing and taking into account efficacy, safety, product labeling, profitability, supply chain considerations, the competitiveness of alternative products sold by Third Parties in the marketplace, the patent and other proprietary position of the product, the likelihood of regulatory approval given the regulatory structure involved, and all other relevant factors, including technical, financial, legal, scientific and/or medical factors and, in any case, that such Party shall assign a budget and responsibility for such task or obligation to employees or contractors of such Party who are held accountable for executing such task or obligation and for monitoring such budget and progress on an ongoing basis. [*] |
1.30 |
“Competitive Activities” has the meaning set forth in Section 2.8(a) (Exclusivity Covenant). |
1.31 |
“Competitive Product” means, with respect to HFB, any [*], and, with respect to FibroGen, any [*], or in the event of the Replacement Option Election, the [*], provided that if (i) FibroGen does not provide an Option Exercise Notice in respect of a given Option Program prior to the expiration of the Option Term for such Option Program or (ii) a Licensed Program becomes a Terminated Licensed Program, then “Competitive Products” will cease to include any [*] that is the subject of such Option Program or Terminated Licensed Program. |
1.32 |
“Confidential Information” has the meaning set forth in Section 12.1 (Confidentiality; Exceptions). |
1.33 |
“Continuing Technology Transfer” has the meaning set forth in Section 2.7(b) (Continuing Technology Transfer). |
1.35 |
“Cover,” “Covering,” or “Covered” means, when used to refer to the relationship between a particular Patent Right and particular subject matter, that the manufacture, use, sale, offer for sale, or importation of such subject matter would fall within the scope of one or more claims in, or is otherwise claimed by, such Patent Right. |
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the company if publicly disclosed.
1.36 |
“CPA Firm” has the meaning set forth in Section 8.7(a) (Books and Records; Audit Rights). |
1.37 |
“CREATE Act” means the Cooperative Research and Technology Enhancement Act of 2004, 35 U.S.C. § 103(c)(2)-(c)(3). |
1.38 |
“CXCR5” means [*]. |
1.39 |
“CXCR5 Option Program” means the program of Development of the Option Compounds and Option Products Directed To CXCR5. |
1.40 |
“Defaulting Party” has the meaning set forth in Section 13.3(c) (Disputes Regarding Material Breach). |
1.42 |
“Development Plan” has the meaning set forth in Section 4.1 (Development Plan). |
1.43 |
“Diligence Milestone” has the meaning set forth in Section 4.4 (Development Diligence Obligations). |
1.44 |
“Directed To” means, as used with respect to a given compound or product and a given target, [*]. |
1.45 |
“Disclosure Letter” has the meaning set forth in Section 10.2 (Representations and Warranties by HFB). |
1.46 |
“Effective Date” has the meaning set forth in the Preamble. |
1.47 |
“EMA” means the European Medicines Agency and any successor agency thereto. |
1.48 |
“Exclusive Target” means each of (a) Gal-9 and (b) after the Option Exercise Date with respect thereto: (i) CXCR5 Option Program, CXCR5; (ii) CCR8 Option Program, CCR8; and (iii) in the event of the Replacement Option Election, Replacement Option Program, the Replacement Target, except for a target to which a Terminated Licensed Program was Directed To. |
1.49 |
“Executive Officer” means (a) in the case of FibroGen, the chief executive officer of FibroGen, and (b) in the case of HFB, the chief executive officer of HFB, neither of whom will be a member of the JSC. |
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the company if publicly disclosed.
1.50 |
“Existing Nondisclosure Agreement” means the Amended and Restated Mutual Confidential Disclosure Agreement entered into by FibroGen, HFB, and HiFiBiO Inc., effective as of [*]. |
1.51 |
“Existing Patent Rights” has the meaning set forth in the definition of Licensed Patent Rights. |
1.53 |
“FD&C Act” has the meaning set forth in Section 1.76 (IND). |
1.54 |
“FDA” means the U.S. Food and Drug Administration or any successor agency thereto. |
1.55 |
“FibroGen” has the meaning set forth in the Preamble. |
1.56 |
“FibroGen Arising Patent Rights” has the meaning set forth in Section 9.2(a)(i) (Arising Technology). |
1.57 |
“FibroGen Background Technology” has the meaning set forth in Section 9.1 (Background Technology). |
1.58 |
“FibroGen CMO” has the meaning set forth in Section 2.7(a) (Initial Technology Transfer). |
1.59 |
“FibroGen Indemnitees” has the meaning set forth in Section 11.1 (Indemnification by HFB). |
1.60 |
“Field” means any and all uses. |
1.61 |
“First Commercial Sale” means, with respect to a Licensed Product in a country or region in the Territory, the first sale to a Third Party of such Licensed Product in such country or region after receipt of Regulatory Approval and, [*]. First Commercial Sale excludes any sale or other distribution of a Licensed Product for promotional or advertising purposes, Clinical Trials, preclinical trials, or other Development purposes, free samples, named patient use, compassionate use, patient assistance, expanded access, or charitable use. |
1.62 |
“FTE Rate” means beginning on the Effective Date, [*] per year. The FTE Rate is subject to annual increases beginning on January 1, 2022 to reflect percentage increase in the Consumer Price Index for the US City Average (all items) for the prior Calendar Year and similarly calculated year to year for each subsequent Calendar Year. |
1.63 |
“Gal-9” means [*]. |
1.64 |
“Gal-9 Licensed Program” means the program of Development and Commercialization of the Licensed Compounds and Licensed Products Directed To Gal-9. |
1.65 |
“GCP” means all applicable Good Clinical Practice standards for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of Clinical Trials, including, as applicable (a) as set forth in the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use Harmonized Tripartite Guideline for Good Clinical Practice (CPMP/ICH/135/95) (the “ICH Guidelines”) and any other guidelines for good clinical practice for trials on medicinal products in the Territory, (b) the Declaration of Helsinki (2004) as last amended at the 52nd World Medical Association in October 2000 and any further amendments or clarifications thereto, (c) U.S. Code of Federal Regulations Title 21, Parts 50 (Protection of Human Subjects), 54 (Financial Disclosure of Clinical Investigators), 56 (Institutional Review Boards) and 312 (Investigational New Drug Application), as may be amended from time to time, and (d) the equivalent applicable laws in the region in the Territory, each as may be amended and applicable from time to time and in each case, that provide for, among other things, assurance that |
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the company if publicly disclosed.
the clinical data and reported results are credible and accurate and protect the rights, integrity, and confidentiality of trial subjects. |
1.66 |
“GLP” means all applicable Good Laboratory Practice standards for nonclinical studies, including, as set forth in the then-current good laboratory practice standards promulgated or endorsed by the U.S. Food and Drug Administration, as set forth in 21 C.F.R. Part 58, and the equivalent applicable laws in the Territory, each as may be amended and applicable from time to time. |
1.67 |
“HFB” has the meaning set forth in the Preamble. |
1.68 |
“HFB Arising Patent Rights” has the meaning set forth in Section 9.2(a)(i) (Arising Technology). |
1.69 |
“HFB Arising Technology” has the meaning set forth in Section 9.2(a)(i) (Arising Technology). |
1.70 |
“HFB Background Technology” has the meaning set forth in Section 9.1 (Background Technology). For clarity, HFB Background Technology includes [*]. |
1.71 |
“HFB Screening Know-How” means Know-How owned or Controlled by HFB prior to or during the Term relating to HFB’s [*]. |
1.72 |
“HFB Screening Patent Rights” means all Patent Rights owned or Controlled by HFB prior to or during the Term claiming, in whole or in part, any HFB Screening Know-How. |
1.73 |
“HFB Screening Technology” means HFB Screening Know-How and HFB Screening Patent Rights. |
1.74 |
“HFB Indemnitees” has the meaning set forth in Section 11.2 (Indemnification by FibroGen). |
1.75 |
“[*]” has the meaning set forth in Section 14.1(b) (Dispute Resolution). |
1.77 |
“Indemnified Party” has the meaning set forth in Section 11.3 (Indemnification Procedures). |
1.78 |
“Indemnifying Party” has the meaning set forth in Section 11.3 (Indemnification Procedures). |
1.79 |
“Initial Technology Transfer” has the meaning set forth in Section 2.7(a) (Initial Technology Transfer). |
1.80 |
“Initiation” or “Initiated” means, with respect to a Clinical Trial of a product, the first dosing of the first human subject pursuant to the applicable protocol for such Clinical Trial. |
1.81 |
“Joint Arising Know-How” has the meaning set forth in Section 9.2(a) (Arising Technology). |
1.82 |
“Joint Arising Patent Rights” has the meaning set forth in Section 9.2(a)(i) (Arising Technology). |
1.83 |
“Joint Arising Technology” has the meaning set forth in Section 9.2(a)(i) (Arising Technology). |
1.84 |
“Joint Steering Committee” and “JSC” have the meaning set forth in Section 3.2(a) (Formation; Composition). |
1.85 |
“Know-How” means any data, results, and information not generally known to the public of any type whatsoever, in any tangible or intangible form, including trade secrets, practices, techniques, methods, processes, inventions, discoveries, developments, specifications, formulations, formulae, |
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the company if publicly disclosed.
materials or compositions of matter of any type or kind (patentable or otherwise), software, algorithms, marketing reports, clinical and non-clinical study reports, clinical and non-clinical data, regulatory filings and regulatory submission documents and summaries, technology, test data including pharmacological, biological, chemical, biochemical, toxicological, and clinical test data, analytical and quality control data, stability data, studies and procedures and any other know-how, and any physical embodiments of any of the foregoing. |
1.86 |
“License Option” has the meaning set forth in Section 2.9(a) (Grant of Options). |
1.88 |
“Licensed Know-How” means [*]. |
1.90 |
“Licensed Product” means any product that contains a Licensed Compound, alone or in combination with one or more therapeutically active pharmaceutical or biological ingredients, in all forms, presentations, compositions, dosages, and formulations. A Licensed Product will be deemed the same Licensed Product if it contains all the same therapeutically active pharmaceutical or biological ingredients. |
1.91 |
“Licensed Program” means the Gal-9 Licensed Program and, after the Option Exercise Date for each Option Program, the CCR8 Option Program, CXCR5 Option Program, and in the event of the Replacement Option Election, the Replacement Option Program, as applicable, but not a Terminated Licensed Program. |
1.92 |
“Licensed Technology” means Licensed Know-How, Licensed Patent Rights, and HFB’s and its Affiliates’ interest in the Joint Arising Technology. |
1.93 |
“Loss of Market Exclusivity” means, on a Licensed Product-by-Licensed Product and country-by-country basis, (a) one or more Biosimilar Products for which such Licensed Product is the reference product have obtained Regulatory Approval and are being legally marketed in such country; and (b) such Biosimilar Products sold in such country achieve, on an aggregate basis, at least [*]. |
1.94 |
“Major Market Country” means any one of the following countries: [*]. |
1.95 |
“Manufacture” or “Manufacturing” means activities directed to manufacturing, processing, packaging, labeling, filling, finishing, assembly, quality assurance, quality control, testing, release for distribution, shipping, or storage of any pharmaceutical or biological product (or any components or process steps involving any product or any companion diagnostic), placebo, or comparator agent, as the case may be, including process development, qualification, and validation, scale-up, pre-clinical, clinical, and commercial manufacture and analytic development, product characterization, and stability testing, but excluding activities directed to Development or Commercialization. “Manufacturing” will be construed accordingly. |
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the company if publicly disclosed.
1.96 |
“NDA” means a New Drug Application submitted to the FDA pursuant to section 505(b)(1) of the FD&C Act, 21 U.S.C. 355(B)(1), and 21 C.F.R.§ 314.50 as these provisions may be amended from time-to-time (or its successor statute or regulation), for purposes of obtaining Regulatory Approval for a pharmaceutical product in the United States, or any equivalent filing in a country or regulatory jurisdiction other than the United States. |
1.97 |
“Net Sales” means, with respect to a Licensed Product and [*] |
For the avoidance of doubt, [*]
In the case of any [*]
If, on a country-by-country basis [*]
If, on a country-by-country basis [*].
1.98 |
“New License Agreement” has the meaning set forth in Section 2.3(b) (Survival of Sublicenses). |
1.99 |
“Non-Defaulting Party” has the meaning set forth in Section 13.3(c) (Disputes Regarding Material Breach). |
1.101 |
“Option Data Package” means, with respect to each Option Program, the information and materials set forth on Schedule 1.101 (Option Data Package). |
1.102 |
“Option Exercise Date” has the meaning set forth in Section 2.9(e) (Exercise of a License Option). |
1.103 |
“Option Exercise Notice” has the meaning set forth in Section 2.9(e) (Exercise of a License Option). |
1.104 |
“Option Exercise Payment” has the meaning set forth in Section 8.2 (Option Exercise Payment). |
1.105 |
“Option Know-How” [*] |
1.106 |
“Option Notice” has the meaning set forth in Section 2.9(c)(i) (Delivery). |
1.107 |
“Option Notice Delivery Date” has the meaning set forth in Section 10.2 (Representations and Warranties by HFB). |
1.108 |
“Option Patent Rights” has the meaning set forth in Section 10.2(f) (Option Technology). |
1.109 |
“Option Product” means any product that contains an Option Compound, alone or in combination with one or more therapeutically active pharmaceutical ingredients, in all forms, presentations, compositions, dosages, and formulations. |
1.110 |
“Option Program” means the CCR8 Option Program, CXCR5 Option Program, or following the Replacement Option Election, the elected Replacement Option Program, as applicable. |
1.111 |
“Option Technology” means Option Know-How and Option Patent Rights. |
1.112 |
“Option Term” has the meaning set forth in Section 2.9(e) (Exercise of a License Option) |
1.113 |
“Other Component” has the meaning set forth in Section 1.27 (Other Component). |
1.114 |
“Party” and “Parties” have the meaning set forth in the Preamble. |
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the company if publicly disclosed.
1.115 |
“Patent Challenge” means any challenge to the validity or enforceability of a Licensed Patent Right or HFB Screening Patent Right used to generate any Licensed Compound, including by (a) filing a declaratory judgment action in which the applicable Licensed Patent Right or HFB Screening Patent Right is alleged to be invalid or unenforceable, (b) becoming party to an interference with the applicable Licensed Patent Right or HFB Screening Patent Right pursuant to 35 U.S.C. §135 or (c) filing or commencing any re-examination, opposition, cancellation, nullity or similar proceedings against the applicable Licensed Patent Right or HFB Screening Patent Right, or petitioning for any form of administrative or judicial (or arbitration) review of the applicable Licensed Patent Right or HFB Screening Patent Right, including post-grant review, inter partes review, or opposition proceedings; provided that the term Patent Challenge shall not include a response to a claim or allegation that FibroGen, its Affiliates or Sublicensees infringes or may infringe any Patent Rights owned or Controlled by HFB, any of its Affiliates, or any of their respective successors or assigns, including in inter partes, post grant review proceedings, oppositions, nullity proceedings, reissue proceedings, reexamination proceedings, and other similar proceedings before the U.S. Patent & Trademark Office or other agency or tribunal in any jurisdiction, or in any arbitration or litigation. |
1.116 |
“Patent Right” means (a) any national, regional, or international patent or patent application, including any provisional patent application, (b) any patent application filed either from such a patent, patent application, or provisional application or from an application claiming priority from any of these, including any divisional, continuation, continuation-in-part, provisional, converted provisional, and continued prosecution application, (c) any patent that has issued or in the future issues from any of the foregoing patent applications ((a) and (b)), including any utility model, xxxxx patent, design patent, and certificate of invention, (d) any extension or restoration by existing or future extension or restoration mechanisms, including any revalidation, reissue, re-examination, and extension (including any supplementary protection certificate and the like) of any of the foregoing patents or patent applications ((a), (b), and (c)), and (e) any similar rights, or any importation, revalidation, confirmation or introduction patent, or registration patent or patent of additions to any such foregoing patent application or patent. |
1.117 |
“Person” means any individual, partnership, joint venture, limited liability company, corporation, firm, trust, association, unincorporated organization, Regulatory Authority, or any other entity not specifically listed in this definition. |
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the company if publicly disclosed.
1.121 |
“Pricing and Reimbursement Approval” means the later of (a) the approval, agreement, determination, or governmental decision establishing a price for a pharmaceutical or biological product that can be legally charged to consumers, if required in a given jurisdiction or country for the Commercialization of such pharmaceutical or biological product in such jurisdiction or country; and (b) the approval, agreement, determination, or governmental decision establishing the level of reimbursement for a pharmaceutical or biological product that will be reimbursed by governmental authorities, in the case of either (a) or (b) if [*] of such pharmaceutical or biological product in such jurisdiction or country. |
1.122 |
“Product Marks” has the meaning set forth in Section 9.6 (Trademarks). |
1.123 |
“Regulatory Approval” means all approvals necessary for the sale of a product for one or more indications in a country or regulatory jurisdiction, which may include satisfaction of all applicable regulatory and notification requirements. Regulatory Approvals include approvals by Regulatory Authorities of [*], NDAs and BLAs and all [*]. |
1.124 |
“Regulatory Authority” means, in a particular country or regulatory jurisdiction, any applicable governmental authority involved in granting Regulatory Approval or, to the extent required in such country or regulatory jurisdiction, Pricing and Reimbursement Approval of a product in such country or regulatory jurisdiction. |
1.125 |
“Regulatory Exclusivity” means any exclusive marketing rights or data exclusivity rights conferred by any Regulatory Authority with respect to a Licensed Product other than Patent Rights, including rights conferred in the U.S. under the FD&C Act, the Public Health Service Act, and the Biologics Price Competition and Innovation Act, including pediatric exclusivity and orphan drug exclusivity, or rights similar thereto outside the U.S. |
1.126 |
“Regulatory Materials” means regulatory applications, submissions, notifications, registrations, or other filings made to or with a Regulatory Authority, and documents and records required by such Regulatory Authority to be maintained or held for inspection, that are necessary in order to Develop, Manufacture, market, sell, or otherwise Commercialize a Licensed Compound or Licensed Product in a particular country or regulatory jurisdiction. Regulatory Materials include INDs, NDAs and BLAs (as applications, but not the approvals with respect thereto). |
1.127 |
“Replacement Option Election” has the meaning set forth in Section 2.9(g)(i) (In Connection with FibroGen Non-Exercise). |
1.128 |
“Replacement Option Program” has the meaning set forth in Section 2.9(g) (Replacement Option Program). |
1.129 |
“Replacement Target” has the meaning set forth in Section 2.9(g) (Replacement Option Program). |
1.130 |
“Royalty” has the meaning set forth in Section 8.4 (Royalties). |
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the company if publicly disclosed.
1.131 |
“Royalty and Net Sales Report” has the meaning set forth in Section 8.4(b) (Reports; Payment). |
1.132 |
“Royalty Term” means, on a country-by-country and Licensed Product-by-Licensed Product basis, the period commencing upon the First Commercial Sale of a Licensed Product in a country, and ending upon the later to occur of (a) the expiration in such country of the last to expire of any Valid Claim of a [*] of the Licensed Compound contained in such Licensed Product in such country; (b) [*] after the First Commercial Sale in such country of such Licensed Product; or (c) expiration of [*] for such Licensed Product in such country. |
1.133 |
[*]. |
1.134 |
“SEC” has the meaning set forth in Section 12.2(b) (Disclosure to SEC). |
1.135 |
“Standby Letter” has the meaning set forth in Section 2.1 (License to FibroGen). |
1.136 |
“Sublicense Revenue” means, non-refundable sublicense upfront fees and sublicense milestone payments made by Sublicensees to FibroGen or any of its Affiliates in consideration of a grant of a sublicense under the rights licensed to FibroGen pursuant to Article 2 (Licenses and Exclusivity) hereof. Notwithstanding the foregoing, and for the avoidance of doubt, it is understood and agreed that Sublicense Revenue shall exclude (a) royalties, (b) amounts received from any Third Party for the purchase of equity (except for equity premiums), reimbursement for research and development performed by FibroGen or by FibroGen’s subcontractor or delegates (specifically designated in a plan for research and/or development by its agreement with Sublicensee) or by Sublicensee, (c) [*], debt financing, (d) reimbursement for patent costs or other patent related expenses, and (e) [*], (f) [*], and (g)[*]. |
1.137 |
“Sublicensee” means any Third Party granted a sublicense by FibroGen under the rights licensed to FibroGen pursuant to Article 2 (Licenses and Exclusivity) hereof. |
1.138 |
“Technology Transfer” has the meaning set forth in Section 2.7(b) (Continuing Technology Transfer). |
1.139 |
“Term” has the meaning set forth in Section 13.1 (Term). |
1.140 |
“Territory” means all countries of the world and all territories and possessions thereof. |
1.141 |
“Termination for Convenience Notice Period” has the meaning set forth in Section 13.2 (Termination by FibroGen). |
1.142 |
“Terminated Licensed Product” has the meaning set forth in Section 13.6 (Effects of Termination). |
1.143 |
“Terminated Licensed Program” has the meaning set forth in Section 13.2 (Termination by FibroGen). |
1.144 |
“Third Party” means any entity other than HFB or FibroGen or their respective Affiliates. |
1.145 |
“Third Party License” has the meaning set forth in Section 2.6 (Third Party In-Licenses). |
1.146 |
“United States” or “U.S.” means the United States of America and all of its territories and possessions. |
1.147 |
“Upfront Payment” has the meaning set forth in Section 8.1 (Upfront Payment). |
1.149 |
“Upstream License Costs” has the meaning set forth in Section 8.6 (Upstream License Costs). |
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the company if publicly disclosed.
1.151 |
“VAT” has the meaning set forth in Section 8.8(e) (VAT). |
1.152 |
“Work Plan” has the meaning set forth in Section 4.2 (Work Plans). |
Article 2
LICENSES AND EXCLUSIVITY
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the company if publicly disclosed.
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the company if publicly disclosed.
|
Manufacturing process data), regulatory correspondence, clinical and pre-clinical data, or other Know-How included within the Licensed Know-How existing as of the Effective Date, including but not limited to documents and information (including any CMC records and information), data (including Manufacturing process data), other Licensed Know-How, or activities, in each case, that are in the possession of HFB, its Affiliates or subcontractors and necessary or reasonably useful to Exploit and Manufacture Licensed Compounds and Licensed Products Directed To Gal-9 and to enable FibroGen or such FibroGen CMO to assume the Manufacturing activities of the Licensed Compounds and Licensed Products Directed To Gal-9. |
|
(ii) |
Other Licensed Programs. With respect to any Licensed Program other than the Gal-9 Licensed Program, within [*] with respect to such Licensed Program and in accordance with a plan to be agreed between the Parties no later than [*], HFB will transfer to FibroGen and/or, at FibroGen’s direction, a FibroGen CMO, electronic copies of all material documents, data, regulatory correspondence, clinical and pre-clinical data, or other Know-How included within the Licensed Know-How with respect to such Licensed Program existing as of the applicable Option Exercise Date, including but not limited to any documents and information (including any CMC records and information), data (including Manufacturing process data), other Licensed Know-How, or activities, in each case, that are in the possession of HFB, its Affiliates or subcontractors and necessary or reasonably useful to Exploit and Manufacture Licensed Compounds and Licensed Products for such Licensed Program and to enable FibroGen or such FibroGen CMO to assume the Manufacturing activities of Licensed Compounds and Licensed Products for such Licensed Program (the transfer described in the foregoing clauses (i) and (ii) with respect to each Licensed Program, the “Initial Technology Transfer”). |
|
(d) |
Third Party Vendors or Contractors. On a Licensed Program-by-Licensed Program basis, at FibroGen’s request, HFB will use Commercially Reasonable Efforts to transfer to |
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the company if publicly disclosed.
|
FibroGen HFB’s relationships with Third Party vendors and contractors that HFB has engaged in the Development or Manufacture of Licensed Compounds and, if any, Licensed Products, by, at FibroGen’s request, introducing FibroGen to such vendors or contractors. |
|
(iii) |
For clarity, the same stage of Development means with respect to the Competitive Product and the applicable Licensed Compound or Licensed Product: [*]. |
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the company if publicly disclosed.
|
(B) |
electronic copies of all submitted filings to a patent office related to the filing, prosecution and maintenance of any Option Patent Rights; |
|
(E) |
a list of all Third Party vendors and contractors that HFB has engaged in the conduct of Development or Manufacturing activities for such Option Program; and |
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the company if publicly disclosed.
|
(ii) |
Additional Information. |
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the company if publicly disclosed.
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the company if publicly disclosed.
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will consist at all times of an equal number of representatives of each of HFB and FibroGen. Each Party may replace its JSC representatives at any time upon written notice to the other Party. If agreed by the JSC on a case-by-case basis, the JSC may invite non-members to participate in the discussions and meetings of the JSC, provided that such participants will have no voting authority at the JSC and are bound by written obligations of confidentiality, non-disclosure, and non-use provisions at least as restrictive or protective of the Parties as those set forth in this Agreement. The JSC will be chaired by an HFB representative prior to the first Option Exercise Date with respect to any Option Program, and thereafter by a representative of FibroGen (each, a “Chairperson”). The role of the Chairperson will be to convene and preside at meetings of the JSC. The Chairperson will have no additional powers or rights beyond those held by the other JSC representatives. The Alliance Managers will work with the Chairperson to prepare and circulate agendas and to ensure the preparation of minutes. |
|
(b) |
Specific Responsibilities. The JSC will: |
|
(i) |
facilitate the provision and exchange of information between the Parties with respect to the Development of the Licensed Compounds and Licensed Products; |
|
(ii) |
oversee the identification and Development of Option Compounds and Option Products; |
|
(iii) |
oversee development of the Option Notice (and all components thereof) for each Option Program; |
|
(iv) |
review, discuss, and determine whether to approve any Technology Transfer plan pursuant to Section 2.7(a) (Initial Technology Transfer) or Work Plan pursuant to Section 4.2 (Work Plans); |
|
(v) |
review, discuss, and determine whether to approve any update or amendment to a Work Plan pursuant to Section 4.2(b) (Work Plans); |
|
(vi) |
review and discuss any Development reports provided by HFB pursuant to Section 4.7 (Development Reports); |
|
(vii) |
establish such additional subcommittees as it deems necessary to achieve the objective and intent of this Agreement, including as necessary to manage the preparation and prosecution of Joint Arising Technology pursuant to Section 9.3(c) (Joint Arising Patent Rights); and |
|
(viii) |
perform such other functions as appropriate, to further the purposes of this Agreement, in each case as agreed in writing by the Parties. |
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the company if publicly disclosed.
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meeting and materials reasonably adequate to enable an informed decision on the matters to be considered. The JSC may meet in person, by videoconference or by teleconference. In-person JSC meetings will be held at locations agreed upon by HFB and by FibroGen. Each Party will bear the expense of its respective JSC members’ participation in JSC meetings. Meetings of the JSC will be effective only if at least [*] are present or participating (including by videoconference or teleconference) in such meeting. The Alliance Managers will be responsible for preparing reasonably detailed written minutes of all JSC meetings that reflect material decisions made and action items identified at such meetings. The Alliance Managers will send draft meeting minutes to each member of the JSC for review and approval within [*] after each JSC meeting. Such minutes will be deemed approved unless [*] members of the JSC objects to the accuracy of such minutes within [*] of receipt. |
|
(c) |
Final Decision-Making Authority. If the Executive Officers are unable to reach consensus on any such matter within [*] days after its submission to them, then: |
|
(i) |
No Changes. Neither Party will have final decision-making authority with respect to approval of a Work Plan pursuant to Section 4.2(a) (Work Plans). |
|
(ii) |
HFB Decisions. HFB will have final decision-making authority with respect to any such matter relating to an Option Program prior to the Option Exercise Date with respect to such Option Program. |
|
(iii) |
FibroGen Decisions. FibroGen will have final decision-making authority with respect to any such matter [*], provided that FibroGen cannot require HFB to perform any activities or incur any costs or expenses that are not included in an approved Work Plan (including any amendments made in accordance with this Agreement). For clarity, such final decision-making authority does not apply to any technology transfer pursuant to Section 2.7 (Technology Transfer). |
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the company if publicly disclosed.
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compliance with any term or condition of this Agreement, or expands such Party’s contractual rights or reduces such Party’s contractual obligations under this Agreement, (B) conflicts with this Agreement, or would be reasonably likely to result in a violation of applicable law, the requirement of any Regulatory Authorities, or result in the infringement or misappropriation of intellectual property rights of any Third Party, or (C) is stated to require the agreement or consent of the Parties under Section 3.3(c)(i) (No Changes). |
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the company if publicly disclosed.
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information. Each such update to a Work Plan will become effective and will supersede the previous version of such Work Plan upon approval thereof by the JSC. Additionally, from time to time prior to dissolution of the JSC, either Party may provide to the JSC a proposed amendment to any then-current Work Plan. The JSC will review and discuss, and determine whether to approve any proposed amendment to the Work Plan in accordance with Section 3.3(c) (Final Decision-Making Authority). |
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the company if publicly disclosed.
Following dissolution of the JSC pursuant to Section 3.4 (Dissolution of JSC), FibroGen will provide to HFB a Development report no later than [*] during the Term summarizing the Development activities performed by or on behalf of FibroGen and its Affiliates and Sublicensees in the Territory for the Licensed Products since the prior such report provided by FibroGen or, in the case of the first such report, since [*] prior to the date upon which the JSC was dissolved pursuant to Section 3.4 (Dissolution of JSC). HFB will have [*] following receipt of such [*] report to reasonably request additional information and a reasonable and prompt opportunity to discuss. Such reports and any additional information provided by a Party regarding Development activities for the Licensed Compounds and Licensed Products, in each case, will be the Confidential Information of the providing Party and subject to the terms of Article 12 (Confidentiality). |
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the company if publicly disclosed.
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the company if publicly disclosed.
such Option Program set forth in Table 8.2 (each, an “Option Exercise Payment”): |
Table 8.2 – Option Exercise Payments |
|||
|
CCR8 Option Program |
CXCR5 Option Program |
Replacement Option Program |
Option Exercise Payment |
[*] |
[*] |
[*] |
Table 8.3(a) – R&D and Regulatory Milestones for each program |
||
No. |
Milestone Event |
Milestone Payment |
1 |
[*] |
[*] |
2 |
[*] |
[*] |
3 |
[*] |
[*] |
4 |
[*] |
[*] |
5 |
[*] |
[*] |
|
Maximum total milestone payments per program |
[*] |
|
Total Maximum |
[*] |
Table 8.3(b) – Sales Milestones for each program |
||
No. |
Milestone Event |
Milestone Payment |
1 |
[*] |
[*] |
2 |
[*] |
[*] |
3 |
[*] |
[*] |
|
Maximum total milestone payments per program |
[*] |
Each milestone payment under this Section 8.3 (Milestone Payments) is non-refundable and non-creditable and payable only once for each Licensed Program, upon the first achievement by FibroGen or its Affiliate or Sublicensee for a Licensed Product Directed To an Exclusive Target in the Territory that is the subject of each such Licensed Program, notwithstanding whether a Licensed Product achieves the milestone event more than once or whether more than one Licensed Product Directed To an Exclusive Target achieves a milestone event. If any of R&D and regulatory milestones events 2 through 5 are achieved by a given Licensed Product prior to achievement of any of the preceding R&D and regulatory milestone events 1 through 4 for such Licensed Product, all preceding milestone events not previously achieved for such Licensed Product shall be deemed to be achieved and payable upon achievement of the applicable R&D
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the company if publicly disclosed.
and regulatory milestone events for such Licensed Product. If [*] events are achieved in the same Calendar Quarter or the same Calendar Year, then [*].
FibroGen will provide HFB with written notice of the achievement of the milestone event in this Section 8.3(a) (R&D and Regulatory Milestones) no later than [*] after the achievement of the applicable milestone event by FibroGen or any of its Affiliates, or within [*] after FibroGen has knowledge of the achievement of the applicable milestone event by a Sublicensee. HFB will invoice FibroGen following receipt of such written notice as soon as reasonably practicable and FibroGen will pay the associated milestone payment no later than [*] after the receipt of such invoice. Such payment will be made by wire transfer of immediately available funds into an account designated by HFB.
Table 8.4(a) – Royalty Rates for Licensed Products |
||
Calendar Year Aggregate Net Sales of a Licensed Product in the Territory |
Royalty Rate |
|
[*] |
[*] |
|
[*] |
[*] |
|
[*] |
[*] |
|
[*] |
[*] |
[*].
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the company if publicly disclosed.
|
|
(iii) |
Cumulative Reductions Floor. In no event will the Royalties due to HFB under this Agreement in a Calendar Year be reduced by more [*] due to HFB pursuant to Section 8.4(a) (Royalty Rates) that would otherwise be due in such Calendar Year for the Licensed Products as a result of the foregoing reductions. |
|
(b) |
The CPA Firm will be given access to and will be permitted to examine such books and records of FibroGen as it will reasonably request, upon [*] prior written notice having been given by HFB, during regular business hours, for the sole purpose of determining compliance with the payment provisions of this Agreement. Prior to any such examination taking place, the CPA Firm will enter into a confidentiality agreement reasonably |
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the company if publicly disclosed.
|
acceptable to FibroGen with respect to the Know-How to which they are given access and will not contain in its report or otherwise disclose to HFB or any Third Party any information labeled by FibroGen as being confidential customer information regarding pricing or other competitively sensitive proprietary information. |
|
(d) |
Within [*] after completion of the CPA Firm’s audit, FibroGen will pay to HFB any deficiency in the payment amount determined by the CPA Firm and, if the deficiency is at least [*] of the total payment amount, then FibroGen shall pay all costs and expenses associated with the CPA Firm’s audit and any dispute thereof pursuant to Section 8.7(c) (Books and Records; Audit Rights). If the report of the CPA Firm shows that FibroGen overpaid, then FibroGen will be entitled to off-set such overpayment against any Royalty then owed to HFB. If no Royalty is then owed to HFB, then HFB will remit such overpayment to FibroGen. |
|
(a) |
Taxes on Net Income. Each Party will be solely responsible for the payment of any and all taxes levied on such Party’s net income. |
|
(b) |
Tax Withholding. The amounts payable pursuant to this Agreement will not be reduced on account of any taxes, unless required by applicable law. If applicable law requires the withholding of taxes on a payment by FibroGen to HFB under this Agreement, then FibroGen will pay the amount of such taxes to the proper governmental authority in a timely manner and will [*]. FibroGen will promptly (as soon as reasonably available) submit to HFB appropriate proof of FibroGen’s payment of the withheld taxes as well as the official receipts in respect thereof. Notwithstanding the foregoing, to the extent there is an increase in the applicable rate of withholding tax on any payments by FibroGen to HFB, which increase is solely as a result of a change in form or domicile of FibroGen, FibroGen shall pay HFB an amount so that after any such additional withholding tax has been taken into account (including as a result of any withholding tax imposed on the additional amounts payable pursuant to this sentence), HFB shall have received an amount from FibroGen equal to the payment HFB would have received had no such additional withholding tax applied. If HFB delivers to FibroGen or the appropriate governmental |
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the company if publicly disclosed.
|
authority in the applicable jurisdiction the prescribed forms necessary to reduce the applicable rate of withholding or to relieve FibroGen of its obligation to withhold taxes, FibroGen will [*], as the case may be, provided that FibroGen is in receipt of evidence, in a form reasonably satisfactory to FibroGen (e.g., HFB’s delivery of all applicable documentation) prior to the time that the applicable payments are due. |
|
(d) |
Certain U.S. Tax Matters. The Parties intend that, for U.S. federal income tax purposes, the license under this Agreement (and the rights transferred upon exercise of the options under this Agreement) represent a sale of intellectual property (i.e., a transfer of all substantial rights in respect of intellectual property as determined for U.S. federal income tax purposes). [*] |
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the company if publicly disclosed.
8.10 |
No Other Compensation. Other than as explicitly set forth (and as applicable) in this Agreement, neither FibroGen nor any of its Affiliates will be obligated to pay any additional fees, milestone payments, royalties or other payments of any kind to or on behalf of HFB or any of its Affiliates under this Agreement. |
Article 9
INTELLECTUAL PROPERTY
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the company if publicly disclosed.
|
Know-How (the “HFB Arising Patent Rights”) will be solely owned by HFB or any of its Affiliates (“HFB Arising Technology”). Arising Know-How invented solely by or on behalf of FibroGen or any of its Affiliates, and all Arising Patent Rights claiming, in whole or in part, any such Arising Know-How (the “FibroGen Arising Patent Rights”), [*] will be solely owned by FibroGen or any of its Affiliates (“FibroGen Arising Technology”). Arising Know-How invented jointly by HFB or any of its Affiliates and FibroGen or any of its Affiliates (“Joint Arising Know-How”), and all Arising Patent Rights claiming, in whole or in part, any such Arising Know-How (the “Joint Arising Patent Rights”) will be jointly owned by both Parties (“Joint Arising Technology”). |
|
(ii) |
HFB will promptly disclose to FibroGen any (A) HFB Arising Technology that is Licensed Technology or (B) Joint Arising Technology, as applicable, developed, created, conceived, or reduced to practice by or on behalf of HFB or any of its Affiliates during the Term. FibroGen will promptly disclose to HFB any FibroGen Arising Technology or Joint Arising Technology, as applicable, developed, created, conceived, or reduced to practice by or on behalf of FibroGen or any of its Affiliates during the Term. |
|
(b) |
HFB Arising Patent Rights. HFB will have the sole right, responsibility and discretion to file, prosecute (including the defense of any oppositions, interferences, reissue proceedings, re-examinations and other post-grant proceedings originating in a patent office), and maintain all HFB Arising Patent Rights at its sole cost and expense, provided, that (i) any HFB Arising Patent Rights that are Option Patent Rights will be subject to |
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the company if publicly disclosed.
|
Section 9.3(d) (Option Patent Rights) and any HFB Arising Patent Rights that are Licensed Patent Rights will be subject to Section 9.3(e) (Licensed Patent Rights). |
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(ii) |
No later than [*], HFB will (A) provide FibroGen, [*], with electronic copies of documents (including file histories and then current dockets) for the applicable Licensed Patent Rights that are in the file maintained by HFB’s in-house or outside patent counsel for such Patent Rights in the Territory or otherwise available to HFB, including any communications, filings and drafts as well as written notice of any pending deadlines or communications for such Licensed Patent Rights (provided, however, that HFB will provide notice of pending deadlines as promptly as possible after the Effective Date so as to ensure adequate time and coordination with respect to such deadlines), and (B) execute and deliver any legal papers reasonably requested by FibroGen to effectuate transfer of control of the filing, prosecution, and maintenance of the Licensed Patent Rights in the Territory. In the event HFB assumes control of the preparation of, filing for, and prosecution and maintenance (including the defense of any oppositions, interferences, reissue |
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the company if publicly disclosed.
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proceedings, re-examinations and other post-grant proceedings originating in a patent office) in the Territory with respect to any Licensed Patent Rights pursuant to Section 9.3(e)(i) (Licensed Patent Rights), then FibroGen will (1) provide HFB with electronic copies of any relevant communications, filings, drafts, and documents not previously provided to HFB as well as written notice of any pending deadlines or communications applicable thereto (including file histories and then current dockets), and (2) execute and deliver any legal papers reasonably requested by HFB to effectuate transfer of control of the filing, prosecution, and maintenance of such Licensed Patent Rights. |
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(iii) |
Each Party will reasonably cooperate with the other Party in the filing, prosecution, defense, and maintenance of the Licensed Patent Rights. Such cooperation includes promptly executing all documents, requiring inventors to be reasonably available to discuss and review applications and other filings, and requiring inventors, subcontractors, employees and consultants and agents of such Party and any of its Affiliates, and for the prosecuting Party and any of its Affiliates and Sublicensees (with respect to FibroGen), to execute all documents, as reasonable and appropriate so as to enable the prosecution and maintenance of any such Licensed Patent Rights. |
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the company if publicly disclosed.
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Rights)), then such Party will notify the other Party promptly, and following such notification, the Parties will confer. FibroGen will have the first right, but will not be obligated, to defend any such action or proceeding in the Territory or bring an infringement action with respect to such infringement in the Territory [*]. FibroGen will promptly inform HFB if it elects not to exercise its first right under this Section 9.5(a) (Enforcement and Cooperation) to defend any such action in the Territory or proceeding or to bring an infringement action, and HFB will thereafter have the second right, but will not be obligated, to defend any such action or proceeding in the Territory or bring an infringement action with respect to such infringement in the Territory [*]. HFB will keep FibroGen reasonably informed of all developments in any action or proceeding. Regardless of which Party exercises its right this Section 9.5(a) (Enforcement and Cooperation), the other Party and its Affiliates will reasonably assist such enforcing Party in any action or proceeding being defended or prosecuted if so requested, and will agree to be named in the filing or join in such action or proceeding if requested by such enforcing Party. If the other Party elects to be represented by legal counsel, then the enforcing Party will bear all of such Party’s related and reasonable legal costs and expenses if the other Party is required to be named in the filing or joined in such action or proceeding or is joined in such action or proceeding at the enforcing Party’s request. |
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the company if publicly disclosed.
Article 10
REPRESENTATIONS, WARRANTIES, AND COVENANTS
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(a) |
Corporate Existence and Power. It is a company or corporation duly organized, validly existing, and in good standing under the laws of the jurisdiction in which it is incorporated, and has full corporate power and authority and the legal right to own and operate its property and assets and to carry on its business as it is now being conducted and as contemplated in this Agreement, including the right to grant the licenses granted by it hereunder. |
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(b) |
Authority and Binding Agreement. (i) It has the corporate power and authority and the legal right to enter into this Agreement and perform its obligations hereunder; (ii) it has taken all necessary corporate action on its part required to authorize the execution and delivery of this Agreement and the performance of its obligations hereunder; and (iii) this Agreement has been duly executed and delivered on behalf of such Party, and constitutes a legal, valid, and binding obligation of such Party that is enforceable against it in accordance with its terms. |
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(c) |
No Conflict. It is not a party to and will not enter into any agreement that would prevent it from granting the rights or exclusivity granted or intended to be granted to the other Party under this Agreement or performing its obligations under this Agreement. |
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the company if publicly disclosed.
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(e) |
Bankruptcy; Insolvency. It and its Affiliates are not subject to any action or petition, pending or otherwise, for bankruptcy or insolvency in any state, country, or other jurisdiction, and it is not aware of any facts or circumstances that could result in such Party or any of its Affiliates becoming or being declared insolvent, bankrupt, or otherwise incapable of meeting its obligations under this Agreement as they become due in the ordinary course of business. |
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(f) |
No Debarment. Neither it nor any of its employees nor to its knowledge, any of the agents performing hereunder, has ever been, is currently, or is the subject of a proceeding that could lead to it or such employees or agents becoming, as applicable, a Debarred Entity or Debarred Individual, an Excluded Entity, or Excluded Individual or a Convicted Entity or Convicted Individual. For purposes of this Agreement, the following definitions will apply: |
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(i) |
A “Debarred Individual” is an individual who has been debarred by the FDA pursuant to 21 U.S.C. §335a (a) or (b) from providing services in any capacity to a person that has an approved or pending drug or biological product application. |
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(ii) |
A “Debarred Entity” is a corporation, partnership or association that has been debarred by the FDA pursuant to 21 U.S.C. §335a (a) or (b) from submitting or assisting in the submission of any abbreviated drug application, or a subsidiary or Affiliate of a Debarred Entity. |
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(iii) |
An “Excluded Individual” or “Excluded Entity” is (A) an individual or entity, as applicable, who has been excluded, debarred, suspended or is otherwise ineligible to participate in federal health care programs such as Medicare or Medicaid by the Office of the Inspector General (OIG/HHS) of the U.S. Department of Health and Human Services, or (B) is an individual or entity, as applicable, who has been excluded, debarred, suspended or is otherwise ineligible to participate in federal procurement and non-procurement programs, including those produced by the U.S. General Services Administration (GSA). |
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(iv) |
A “Convicted Individual” or “Convicted Entity” is an individual or entity, as applicable, who has been convicted of a criminal offense that falls within the ambit of 21 U.S.C. §335a (a) or 42 U.–.C. §1320a - 7(a), but has not yet been excluded, debarred, suspended, or otherwise declared ineligible. |
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the company if publicly disclosed.
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liens, charges, security interests, and encumbrances or licenses and (ii) claims or covenants, in each case that would conflict with or limit the scope of any of the rights or licenses granted to FibroGen hereunder, or would give rise to any Third Party claims for payment against FibroGen or any of its Affiliates. HFB is entitled to grant the license granted to FibroGen under Section 2.1 (License to FibroGen), and HFB has taken all appropriate measures under all applicable laws to grant such licenses. |
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(b) |
No Notice of Infringement or Misappropriation. (i) Neither HFB nor any of its Affiliates have received or is aware of any written notice from any Third Party asserting or alleging that any Exploitation of any Licensed Technology, any Licensed Compound, any Option Technology, or any Option Compound has infringed or misappropriated, or would infringe or misappropriate, the intellectual property rights of any Third Party, and (ii) no claim is pending, and HFB and any of its Affiliates and, to HFB’s knowledge, any Third Party collaborator, has not received from a Third Party notice of a claim or threatened claim to the effect that any granted Patent Right rights within the Licensed Technology licensed to FibroGen under this Agreement, or the Option Technology, is invalid or unenforceable. To HFB’s knowledge, the Exploitation of the Licensed Compound, and Option Compound as contemplated hereunder will not infringe, misappropriate, or otherwise violate the intellectual property rights of any Third Party. Additionally, to HFB’s knowledge, there is no unauthorized use, infringement or misappropriation of any Licensed Technology or Option Technology by any Third Party as of the Effective Date. |
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(e) |
Option Programs. (i) HFB has the right to use all Option Technology to Exploit the Option Compounds in the Territory as contemplated under this Agreement; and (ii) the Development, Commercialization, or other Exploitation of the Option Compounds as contemplated herein will not conflict with any other license or agreement to which HFB or any of its Affiliates is a party. |
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the company if publicly disclosed.
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(i) |
All Material Information Furnished. HFB has furnished or made available to FibroGen or its agents or representatives (i) all [*] requested by FibroGen, (ii) all material safety and efficacy data, (iii) all material regulatory filings and other correspondence with Regulatory Authorities, and (iv) [*], in each case ((i) through (iv)), concerning the Licensed Compounds, the Option Compounds, the Licensed Technology and the Option Technology. All such material information and data, regulatory filings and other correspondence with Regulatory Authorities is [*]. |
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(j) |
Conduct of Research and Development. HFB and its Affiliates have conducted all Development of Licensed Compound and Option Compound in accordance with all Applicable Law. |
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(m) |
Downstream Licenses. Neither HFB nor any of its Affiliates have granted to any Third Party a license, covenant not to xxx, option, or other right with respect to any Licensed Compound, or Option Compound in the Territory. |
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(n) |
Consents. Without limitation to Section 10.1(d) (Consents), each Party and its Affiliates have obtained all consents, approvals, and authorizations from all governmental authorities |
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the company if publicly disclosed.
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required to be obtained by such Party or its Affiliates in connection with this Agreement and, as between the Parties, the Party responsible for obtaining any such consent, approval or authorization will be [*] to any governmental authority for the failure by such Party or its Affiliates to obtain any such consent, approval or authorization. |
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(a) |
No Conflicting Grants. Following the Effective Date, HFB will not, and will cause its Affiliates not to, enter into any agreement with any Affiliate or Third Party that materially conflicts with or contradicts the terms and conditions set forth in this Agreement, including any agreement that would limit the grant of licenses or rights hereunder to the Licensed Technology or Option Technology. |
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(c) |
Control of Licensed Technology. HFB and its Affiliates will (a) maintain (i) ownership or Control of all Licensed Technology owned by HFB or its Affiliates at any time during the Term and (ii) Control of all Licensed Technology in-licensed by HFB or its Affiliates at any time during the Term, and (b) not assign, transfer, encumber, or otherwise grant any Third Party any rights with respect thereto, in the case of either (a) or (b) that would conflict with, limit the scope of, or materially adversely affect the rights granted to FibroGen under this Agreement; |
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the company if publicly disclosed.
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(a) |
Compliance with Applicable Law. Each Party will comply, and will ensure that its Affiliates, Sublicensees, and subcontractors will comply, with the applicable law, including as applicable GLP, GCP, and cGMP and any applicable anti‑corruption or anti‑bribery laws or regulations of any governmental authority with jurisdiction over the activities performed by or on behalf of such Party or its Affiliates, Sublicensees, and subcontractors in each case, in the course of performing its obligations or exercising its rights pursuant to this Agreement. Neither Party nor its Affiliates, Sublicensees, and subcontractors will knowingly engage any agent to perform activities under this Agreement that has ever been, is currently, or is the subject of a proceeding that could lead to it or such employees or agents becoming, as applicable, a Debarred Entity or Debarred Individual, an Excluded Entity or Excluded Individual, or a Convicted Entity or Convicted Individual. |
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(b) |
Assignment of Inventions. Each Party will ensure, and will ensure that its Affiliates, Sublicensees, and subcontractors ensure that, any and all Persons involved in or performing any activities under this agreement by or on behalf of such Party have an obligation to assign such Persons’ rights, title, and interests in and to any Know-How and Patent Rights to such Party prior to any such person performing such activities. As between the Parties, each Party, Sublicensees, and subcontractors will be solely responsible for the payment of, and such will pay, any rewards, remuneration, or other amounts payable with respect to inventions and technical achievements required by applicable law to be paid to its and its Affiliates’, Sublicensees’, and subcontractors’ employees, consultants, contractors, or other Persons for the development or invention of any Know-How or Patent Rights; and |
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(c) |
Debarment. In the performance of activities under this Agreement, each Party will not knowingly employ or use any Person that: (i) has ever been debarred or is subject to debarment or convicted of a crime for which an entity or person could be a Debarred Entity or Debarred Individual; or (ii) has ever been under indictment for a crime for which a person or entity could be so debarred. Each Party will inform the other Party in writing immediately if it or any Person that is performing activities under this Agreement is debarred or is subject to debarment or is the subject of a conviction described in Section 306 of the FD&C Act, or if any action, suit, claim, investigation, or legal or administrative proceeding is pending or threatened, relating to the debarment or conviction of such Party or any Person or entity used in any capacity by such Party or any of its Affiliates, Sublicensees, and subcontractors with respect to this Agreement or the performance of its other obligations or exercise of its rights under this Agreement. |
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(d) |
Consents. In the event that either Party determines that HFB would have been, [*] in breach of Section 10.2(n), but for the [*], such Party will notify the other in writing and provide all relevant information with respect thereto. The Parties will thereafter work together promptly in good faith, [*] to take all steps necessary in order to remedy such breach (including, if required, obtaining all consents, approvals and authorizations from all government authorities and paying any amounts required by applicable law to be paid to any governmental authority for the failure by such Party or its Affiliates to obtain any such consent, approval or authorization). |
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the company if publicly disclosed.
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the company if publicly disclosed.
consultant, contractor of FGEN or its Affiliate or Sublicensee who is an inventor of any Patent Right with respect to the ownership thereof; excluding, in each case ((a), (b), (c), (d), and (e)), any damages or other amounts for which HFB has an obligation to indemnify any FibroGen Indemnitee pursuant to Section 11.1 (Indemnification by HFB). |
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the company if publicly disclosed.
(WHETHER IN CONTRACT, TORT (INCLUDING NEGLIGENCE), STRICT LIABILITY OR OTHERWISE), REGARDLESS OF ANY NOTICE OF THE POSSIBILITY OF SUCH DAMAGES. NOTWITHSTANDING THE FOREGOING, NOTHING IN THIS SECTION 11.4 (LIMITATION OF LIABILITY) IS INTENDED TO OR WILL LIMIT OR RESTRICT (A) THE INDEMNIFICATION RIGHTS OR OBLIGATIONS OF ANY PARTY UNDER SECTION 11.1 (INDEMNIFICATION BY HFB) OR SECTION 11.2 (INDEMNIFICATION BY FIBROGEN), (B) DAMAGES AVAILABLE IN THE CASE OF A PARTY’S FRAUD, GROSS NEGLIGENCE, OR INTENTIONAL MISCONDUCT, OR (C) DAMAGES AVAILABLE TO A PARTY FOR A BREACH BY THE OTHER PARTY OF THE CONFIDENTIALITY OBLIGATIONS UNDER Article 12 (CONFIDENTIALITY), MISAPPROPRIATION OR INFRINGEMENT OF INTELLECTUAL PROPERTY RIGHTS, OR THE OTHER PARTY’S BREACH OF ITS OBLIGATIONS UNDER SECTION 2.8 (EXCLUSIVITY). |
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the company if publicly disclosed.
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the company if publicly disclosed.
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give reasonable advance notice to the other Party of such disclosure requirement and, in each of the foregoing, will use its reasonable efforts to secure confidential treatment of such Confidential Information required to be disclosed and will only disclose that Confidential Information that is required to be disclosed; (iii) to advisors (including lawyers and accountants) on a need to know basis, in each case under appropriate confidentiality provisions or professional standards of confidentiality substantially equivalent to those of this Agreement, or (iv) to the extent agreed to by the Parties. |
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the company if publicly disclosed.
faults and all representations and warranties disclaimed and at its sole risk. |
Article 13
TERM AND TERMINATION
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the company if publicly disclosed.
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Agreement in part with respect to those Licensed Programs (and all Licensed Products that include such Licensed Compound) to which such material breach relates or the Agreement as a whole at any time during the Term of this Agreement by written notice of termination to FibroGen. |
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(a) |
Bankruptcy. Either Party may terminate this Agreement in its entirety upon providing written notice to the other Party upon a Bankruptcy Event of the other Party. |
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(b) |
Bankruptcy Laws. All rights and licenses granted under or pursuant to this Agreement are, and shall otherwise be deemed to be, for purposes of Section 365(n) of Title 11 of the United States Code, as amended (the “Bankruptcy Code”), or similar laws of any applicable state, the U.S., or foreign jurisdiction (collectively, the “Bankruptcy Laws”), licenses of rights to “intellectual property” as defined under the Bankruptcy Laws and are to include trademarks and trade names. In the event the Bankruptcy Laws in a jurisdiction outside the US do not have provisions similar to those in Section 365(n) of the Bankruptcy Code, the Parties acknowledge and agree that it is the intention of the Parties to incorporate such rights and remedies herein and the non-bankrupt Party may elect for this Agreement to be treated in accordance with Section 365(n) of the Bankruptcy Code in such jurisdiction. |
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(c) |
If a Bankruptcy Event occurs with respect to a Party during the Term under any Bankruptcy Laws: |
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(i) |
unless and until this Agreement is rejected as provided pursuant to such Bankruptcy Laws, such Party (in any capacity, including debtor-in-possession) and its successors and assigns (including a trustee under the Bankruptcy Code or other applicable Bankruptcy Laws) shall perform all of the obligations in this Agreement intended to be performed by such Party. |
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the company if publicly disclosed.
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(ii) |
if this Agreement is rejected as provided for under the Bankruptcy Laws, and the non-bankrupt Party elects to retain its rights hereunder as provided for under the Bankruptcy Laws, then the Party subject to such Bankruptcy Event (in any capacity, including debtor-in-possession) and its successors and assigns (including a trustee under the Bankruptcy Code or other applicable Bankruptcy Laws), shall provide to the non-bankrupt Party copies (or complete access to, as appropriate) of all Patent Rights and other information necessary for the non-bankrupt Party to prosecute, maintain and enjoy its rights under the terms of this Agreement. All rights, powers and remedies of the non-bankrupt Party as provided herein are in addition to and not in substitution for any and all other rights, powers and remedies now or hereafter existing at law or in equity (including the Bankruptcy Laws) in a Bankruptcy Event of the Party under the Bankruptcy Laws. In particular, it is the intention and understanding of the Parties to this Agreement that the rights granted to the Parties under this Section 13.4 (Termination for Bankruptcy) are essential to the Parties’ respective businesses and the Parties acknowledge that damages are not an adequate remedy. The Parties acknowledge and agree that the payments made under Section 8.4 (Royalties) shall (A) constitute royalties within the meaning of Section 365(n) of the Bankruptcy Code or any analogous provisions under other Bankruptcy Laws, and (B) relate to licenses of Intellectual Property. In the event that this Agreement is rejected or deemed rejected under the Bankruptcy Laws, the Party subject to such Bankruptcy Event (or its Representative, assignee or trustee in such case or proceeding) shall provide written notice thereof to the other Party. The Parties waive all rights to object to the application of Section 365(n) of the Bankruptcy Code or similar provisions under Bankruptcy Laws. |
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the company if publicly disclosed.
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(b) |
Reversion Rights. At HFB’s written request, FibroGen hereby agrees to [*] which FibroGen will and hereby does as of the effective date of termination: |
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(ii) |
effect a technology transfer to facilitate HFB’s practice of such license; |
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(iii) |
[*] |
[*]
In addition, if HFB reasonably believes that HFB requires a non-exclusive license under FibroGen Background Technology in order to Exploit such Terminated Licensed Product and provides a written request to FibroGen, FibroGen shall (to the extent it is permitted to do so) negotiate in good faith with HFB for commercially reasonable terms under which FibroGen will grant to HFB such license.
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(i) |
Transfer to HFB. If, as of the effective date of termination of this Agreement with respect to a Licensed Product, FibroGen or its Affiliates are conducting any Clinical Trials for such Licensed Product, then, at HFB’s election on a Clinical Trial-by-Clinical Trial basis, FibroGen will either (A) reasonably cooperate, and ensure that its Affiliates reasonably cooperate, with HFB to transfer the conduct of such Clinical Trial (including any data, trial master files and clinical and safety databases) to HFB or its designees, or (B) subject to FibroGen’s approval, continue to conduct such Clinical Trial, at HFB’s cost (unless this Agreement is terminated by HFB pursuant to Section 13.3 (Termination for Cause) [*] for the conduct of such transferred Clinical Trial for such Licensed Products after the transfer date. |
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(ii) |
Wind-Down. If HFB does not elect to assume control of any such Clinical Trials for any Licensed Product, then FibroGen will, in accordance with accepted pharmaceutical industry norms and ethical practices, wind-down the conduct of any such Clinical Trial in an orderly manner. FibroGen will be responsible for any costs and expenses associated with such wind-down (unless this Agreement is terminated by FibroGen pursuant to Section 13.3 (Termination for Cause), in which case HFB will bear all such costs and expenses). |
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the company if publicly disclosed.
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the company if publicly disclosed.
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(a) |
In the event of any dispute between the Parties under this Agreement, the Parties will first attempt in good faith to resolve such dispute by negotiation and consultation between themselves. In the event that such dispute is not resolved on an informal basis within fifteen (15) Business Days, either Party may refer the matter to the Executive Officers of the Parties for attempted resolution, whereupon the Executive Officers will confer and attempt in good faith to resolve such dispute by negotiation and consultation for a thirty (30) day period following such referral. |
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(d) |
The arbitrators will use their best efforts to rule on each disputed issue within thirty (30) days after the completion of any hearings associated with the arbitration. Either party may apply to the arbitrators seeking injunctive relief until the arbitration award is rendered or the controversy is otherwise resolved. The arbitrators may enter early or summary disposition of some or all issues, after the Parties have made reasonable submissions on those issues. The determination of the arbitrators as to the resolution of any dispute will be binding and conclusive upon all Parties and their respective Affiliates and any agents, principals, officers, directors, or employees of either of the Parties and their respective Affiliates. The arbitrators will issue a written award that contains a reasoned opinion setting forth the findings of fact and conclusions upon which the award is based, including the |
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the company if publicly disclosed.
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calculation of any damages awarded. A judgment on any award rendered by the arbitrators may be entered in any court having jurisdiction thereof. |
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(e) |
The (i) attorneys’ fees of the Parties in any arbitration, (ii) fees of the arbitrators and (iii) costs and expenses of the arbitration will be allocated among the Parties as determined by the arbitrators, who shall have discretion to make this determination equitably, taking into account (A) which party prevailed, in the view of the arbitrators, (B) whether any party caused unnecessary delay, burden or expense, and (C) the reasonability of the attorneys’ fees, costs, and expenses requested. |
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(f) |
Any arbitration pursuant to this Section 14.1 (Dispute Resolution) will be conducted in [*]. |
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(g) |
The Parties intend that each award by an arbitrators in an arbitration pursuant to this Section 14.1 (Dispute Resolution) will be rendered in accordance with the United Nations Convention on the Recognition and Enforcement of Arbitral Awards and will be enforceable in accordance therewith. |
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(h) |
The arbitrators will take appropriate actions to prevent, remediate, and/or sanction abusive conduct or other actions that threaten to undermine the fair, speedy and cost-effective resolution of the matter. |
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(i) |
Except to the extent necessary to confirm an award or as may be required by law, neither Party nor an arbitrator may disclose the existence, content, or results or any arbitration without the prior written consent of both Parties. |
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(j) |
In addition, during the pendency of any dispute under this Agreement initiated before the end of any applicable cure period under Section 13.3 (Termination for Cause), (i) this Agreement will remain in full force and effect, (ii) the provisions of this Agreement relating to termination for material breach will not be effective, (iii) the time periods for cure under 13.3 (Termination for Cause) as to any termination notice given prior to the initiation of the proceeding will be tolled, and (iv) neither Party will issue a notice of termination pursuant to this Agreement based on the subject matter of the proceeding (and no effect will be given to previously issued termination notices), until the arbitrators have confirmed the existence of the facts claimed by a Non-Defaulting Party to be the basis for the asserted material breach. |
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the company if publicly disclosed.
accordance with 13.3 (Termination for Cause). |
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the company if publicly disclosed.
international expedited delivery service, (b) five (5) Business Days after mailing, if mailed by first class certified or registered mail, postage prepaid, return receipt requested, or (c) by email, if confirmed by the intended recipient. This Section 15.3 (Notices) is not intended to govern the day-to-day business communications necessary between the Parties in performing their obligations under the terms of this Agreement. |
If to HFB:
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Attention: [*] |
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With a copy to (which will not constitute notice): |
HiFiBiO Therapeutics Xxxxxxxxx, XX, 00000
Attention: [*] |
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and: |
Xxxxx Xxxx Attention: [*] |
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If to FibroGen: |
FibroGen, Inc. 000 Xxxxxxxx Xxxxxx Xxx Xxxxxxxxx, XX 00000 |
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Attention: [*]
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With a copy to (which will not constitute notice):
and: |
FibroGen, Inc. 000 Xxxxxxxx Xxxxxx Xxx Xxxxxxxxx, XX 00000
Attention: [*] Email: [*]
Ropes & Xxxx 0000 Xxxxxxxxxx Xxxxxx, 0xx Xxxxx Xxxx Xxxx Xxxx, XX 00000
Attention: [*] |
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the company if publicly disclosed.
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the company if publicly disclosed.
of this Agreement. Accordingly, the rule of construction that any ambiguity in this Agreement will be construed against the drafting Party will not apply. |
15.10 |
Severability. If any one or more of the provisions of this Agreement is held to be invalid or unenforceable by the arbitrators or by any court of competent jurisdiction from which no |
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the company if publicly disclosed.
appeal can be or is taken, then the provision will be considered severed from this Agreement and will not serve to invalidate any remaining provisions hereof. The Parties will make a good faith effort to replace any invalid or unenforceable provision with a valid and enforceable one such that the objectives contemplated by the Parties when entering into this Agreement may be realized. |
15.13 |
Counterparts. This Agreement may be executed in one or more counterparts, each of which will be deemed an original, but all of which together will constitute one and the same instrument. |
15.14 |
Choice of Law. This Agreement will be governed by, and enforced and construed in accordance with, the laws of the State of Delaware, without regard to its conflicts of law provisions. |
[Signature Page Follows]
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the company if publicly disclosed.
IN WITNESS WHEREOF, the Parties have executed this Agreement by their duly authorized representatives as of the Effective Date.
HIFIBIO (HK) LIMITED (D.B.A. HIFIBIO THERAPEUTICS) |
FIBROGEN, INC. |
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By:/s/ Xxxxx Xxxxxxxxx |
By:/s/ Xxxxxxx Xxxxxxxx |
Name:Xxxxx Xxxxxxxxx, Ph. D. |
Name:Xxxxxxx Xxxxxxxx |
Title:Chief Executive Officer |
Title:Chief Executive Officer |
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[Signature Page to Exclusive License and Option Agreement]
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the company if publicly disclosed.
SCHEDULE 1.87
[*]
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the company if publicly disclosed.
SCHEDULE 1.89
Licensed Patent Rights
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[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the company if publicly disclosed.
SCHEDULE 1.101
Option Data Package
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[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the company if publicly disclosed.
Option Package for Replacement Program
To be determined by the parties in reasonable. [*].
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the company if publicly disclosed.
SCHEDULE 2.7(a)
Initial Technology Transfer
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[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the company if publicly disclosed.
SCHEDULE 4.1
Development Plan
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[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the company if publicly disclosed.
SCHEDULE 4.2
Work Plans
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[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the company if publicly disclosed.
SCHEDULE 10.2
Disclosure Schedule
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the company if publicly disclosed.
SCHEDULE 10.3(e)
Negative Events
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[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the company if publicly disclosed.
SCHEDULE 12.2(c)
Initial Press Release
FibroGen and HiFiBiO Announce Transformative Partnership to
Advance Next-Generation Therapies for Patients with Cancer and Autoimmune Disease
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FibroGen Exclusively Licenses HiFiBiO’s Galectin-9 Program, and Obtains an Exclusive Option to their CXCR5 and CCR8 Programs |
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Transformative Transaction for FibroGen’s Early-stage Pipeline |
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HiFiBiO to Receive $25 Million Upfront, and Up to a Total of $1.1B in Additional Milestone Payments Across All Three Programs, Plus Royalties |
SAN FRANCISCO, CA and CAMBRIDGE, MA, June 17, 2021 (GLOBE NEWSWIRE) – FibroGen, Inc. (Nasdaq: FGEN) and HiFiBiO Therapeutics, a private, multinational clinical-stage biotherapeutics company with expertise in immune modulation and single cell science announced a partnership covering three HiFiBiO programs.
“We are very pleased to add the HiFiBiO drug candidates to our pre-clinical development pipeline,” said Xxxxxxx Xxxxxxxx, Chief Executive Officer, FibroGen. “With the addition of up to three programs in the immuno-oncology and autoimmune space, we have the potential to transform our early development pipeline.”
“The FibroGen partnership represents significant validation of our Drug Intelligent Science (DIS™) approach and deep expertise in disease biology and translation science,” said Xxxxx Xxxxxxxxx, Ph.D., Chief Executive Officer, HiFiBiO. “As another successful showcase of our open innovation approach, we look forward to working closely with FibroGen, an exciting, growing biopharmaceutical company.”
Under the terms of the agreement, FibroGen will make a $25 million upfront payment to HiFiBiO, as well as payments upon option exercise. In addition, HiFiBiO may receive up to a total of an additional $1.1B in future option, clinical, regulatory, and commercial milestone payments across all three programs. HiFiBiO will also be eligible to receive royalties based upon worldwide net sales.
FibroGen exclusively licensed all products in the Galectin-9 program and will have sole right to develop them worldwide. The lead product candidate in the Galectin-9 program is expected to enter clinical development in the first quarter of 2023. FibroGen has also obtained exclusive options to license all product candidates in HiFiBiO’s CXCR5 and CCR8 programs. Each option may be independently exercised following delivery of program-specific data to be generated by HiFiBiO. If an option is exercised, FibroGen will have the sole right to develop products from that program worldwide. The lead product candidates from the CXCR5 and CCR8 programs are expected to enter clinical development by the middle of 2023.
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the company if publicly disclosed.
“We look forward to a productive partnership with HiFiBiO, a leader in the field of single-cell science for antibody discovery and translational medicine,” said Xxxx Xxxxxx, M.D, M.P.H, Chief Medical Officer, FibroGen. “We are excited to bring the Galectin-9 antibody program into the FibroGen portfolio. As Galectin 9 plays a role in suppressing the anti-tumor immune response in both myeloid malignancies and solid tumors, we believe this antibody candidate from HiFiBiO can advance the treatment of cancer in combination with chemotherapy or other immuno-oncology agents. The exclusive option to access projects directed to CXCR5 and CCR8 provides additional opportunities to expand our therapeutic area focus on oncology and immunology. These are both important biological targets playing clear roles in autoimmune disease and cancer.”
About FibroGen
FibroGen, Inc. is a biopharmaceutical company committed to discovering, developing, and commercializing a pipeline of first-in-class therapeutics. The Company applies its pioneering expertise in hypoxia-inducible factor (HIF) and connective tissue growth factor (CTGF) biology to advance innovative medicines for the treatment of unmet needs. The Company is currently developing and commercializing roxadustat, an oral small molecule inhibitor of HIF prolyl hydroxylase activity, for anemia associated with chronic kidney disease (CKD). Roxadustat is also in clinical development for anemia associated with myelodysplastic syndromes (MDS) and for chemotherapy-induced anemia (CIA). Pamrevlumab, an anti-CTGF human monoclonal antibody, is in clinical development for the treatment of locally advanced unresectable pancreatic cancer (LAPC), Duchenne muscular dystrophy (DMD), and idiopathic pulmonary fibrosis (IPF). For more information, please visit xxx.xxxxxxxx.xxx.
About HiFiBiO Therapeutics
HiFiBiO Therapeutics is transforming the field of immunotherapy by combining proprietary single-cell profiling technologies with advanced data intelligence and deep knowledge of immune system biology. This approach enables the development of novel antibody therapies that are paired with biomarkers to predict patient response. HiFiBiO Therapeutics is working actively to address unmet medical needs around the world through its own innovative pipeline programs and open-innovation partnerships with world-renowned industry and academic researchers. The company’s strong global footprint features cutting-edge laboratories on three continents, in Cambridge, Mass., Paris, Shanghai, and Hong Kong. To learn more, please visit xxx.xxxxxxx.xxx.
Forward-Looking Statements
This release contains forward-looking statements regarding our strategy, future plans and prospects, including statements regarding the development and commercialization of the company’s product candidates, the potential safety and efficacy profile of our product candidates, our clinical programs and regulatory events, and those of our partners. These forward-looking statements include, but are not limited to, statements about our plans, objectives, representations and contentions and are not historical facts and typically are identified by use of terms such as “may,” “will”, “should,” “on track,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue” and similar words, although some forward-looking statements are expressed differently. Our actual results may differ materially from those indicated in these forward-looking statements due to risks and
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the company if publicly disclosed.
uncertainties related to the continued progress and timing of our various programs, including the enrollment and results from ongoing and potential future clinical trials, and other matters that are described in our Annual Report on Form 10-K for the fiscal year ended December 31, 2020 and our Quarterly Report on Form 10-Q for quarter ended March 31, 2021 filed with the Securities and Exchange Commission (SEC), including the risk factors set forth therein. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release, and we undertake no obligation to update any forward-looking statement in this press release, except as required by law.
Contacts:
FibroGen, Inc.
Investors:
Xxxxxxx Xxxx, M.D.
Corporate Strategy / Investor Relations
415.978.1434
xxxxx@xxxxxxxx.xxx
Media:
GCI Health
XxxxxXxxXxxxx@xxxxxxxxx.xxx
Contacts:
HiFiBiO Therapeutics
Investors:
Xxxxxxx Xxx
617.395.1212
xxxxx@xxxxxxx.xxx
Media:
Xxxxxxx Xxx
617.395.1212
xxxxx@xxxxxxx.xxx
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the company if publicly disclosed.